Using patient-reported outcome measures during the management of patients with end-stage kidney disease requiring treatment with haemodialysis (PROM-HD): a qualitative study

Objectives Patients undergoing haemodialysis report elevated symptoms and reduced health-related quality of life, and often prioritise improvements in psychosocial well-being over long-term survival. Systematic collection and use of patient-reported outcomes (PROs) may help support tailored healthcare and improve outcomes. This study investigates the methodological basis for routine PRO assessment, particularly using electronic formats (ePROs), to maximise the potential of PRO use, through exploration of the experiences, views and perceptions of patients and healthcare professionals (HCPs) on implementation and use of PROs in haemodialysis settings. Study design Qualitative study. Setting and participants Semistructured interviews with 22 patients undergoing haemodialysis, and 17 HCPs in the UK. Analytical approach Transcripts were analysed deductively using the Consolidated Framework for Implementation Research (CFIR) and inductively using thematic analysis. Results For effective implementation, the potential value of PROs needs to be demonstrated empirically to stakeholders. Any intervention must remain flexible enough for individual and aggregate use, measuring outcomes that matter to patients and clinicians, while maintaining operational simplicity. Any implementation must sit within a wider framework of education and support for both patients and clinicians who demonstrate varying previous experience of using PROs and often confuse related concepts. Implementation plans must recognise the multidimensionality of end-stage kidney disease and treatment by haemodialysis, while acknowledging the associated challenges of delivering care in a highly specialised environment. To support implementation, careful consideration needs to be given to barriers and facilitators including effective leadership, the role of champions, effective launch and ongoing evaluation. Conclusions Using the CFIR to explore the experiences, views and perceptions of key stakeholders, this study identified key factors at organisational and individual levels which could assist effective implementation of ePROs in haemodialysis settings. Further research will be required to evaluate subsequent ePRO interventions to demonstrate the impact and benefit to the dialysis community.


ABSTRACT
Objectives Patients undergoing haemodialysis report elevated symptoms and reduced health-related quality of life, and often prioritise improvements in psychosocial well-being over long-term survival. Systematic collection and use of patient-reported outcomes (PROs) may help support tailored healthcare and improve outcomes. This study investigates the methodological basis for routine PRO assessment, particularly using electronic formats (ePROs), to maximise the potential of PRO use, through exploration of the experiences, views and perceptions of patients and healthcare professionals (HCPs) on implementation and use of PROs in haemodialysis settings. Study design Qualitative study. Setting and participants Semistructured interviews with 22 patients undergoing haemodialysis, and 17 HCPs in the UK. Analytical approach Transcripts were analysed deductively using the Consolidated Framework for Implementation Research (CFIR) and inductively using thematic analysis. Results For effective implementation, the potential value of PROs needs to be demonstrated empirically to stakeholders. Any intervention must remain flexible enough for individual and aggregate use, measuring outcomes that matter to patients and clinicians, while maintaining operational simplicity. Any implementation must sit within a wider framework of education and support for both patients and clinicians who demonstrate varying previous experience of using PROs and often confuse related concepts. Implementation plans must recognise the multidimensionality of end-stage kidney disease and treatment by haemodialysis, while acknowledging the associated challenges of delivering care in a highly specialised environment. To support implementation, careful consideration needs to be given to barriers and facilitators including effective leadership, the role of champions, effective launch and ongoing evaluation. Conclusions Using the CFIR to explore the experiences, views and perceptions of key stakeholders, this study identified key factors at organisational and individual levels which could assist effective implementation of ePROs in

INTRODUCTION
The prevalence of end-stage kidney disease (ESKD) requiring treatment with renal replacement therapies such as haemodialysis (HD) continues to rise worldwide. 1 Both underlying disease and treatment are associated with a high symptom burden and reduced health-related quality of life (HRQoL). 2 3 Historically, outcomes such as mortality and Strengths and limitations of this study ► Qualitative methods yield rich data with face-to-face semistructured interviews allowing the interviewer to monitor non-verbal communications and clarify ambiguous responses. ► This study involved explorations of a prospective intervention, meaning some participants were unfamiliar with key concepts. Preinterview materials were shared to support and inform discussion and participation. ► The role of the researchers was carefully considered to acknowledge and minimise bias associated with beliefs and values. Steps were taken to mitigate risks, including use of reflective diaries, participant checking and multiple researchers involved in the coding process. ► While purposive sampling methods led to a diverse sample of participants, it is acknowledged that the sample did not include non-English speakers or carers. Further research is required. ► Data were collected before the coronavirus pandemic. The healthcare delivery landscape in the UK has changed, and it is possible that some attitudes and beliefs particularly around digital data capture may have evolved.
Open access dialysis adequacy based on biomedical parameters have been used to inform the management of dialysis services and individual care. 4 However, there is now a body of established research [5][6][7][8][9][10] demonstrating the importance of also capturing patient-reported outcomes (PROs). PRO measures capture data directly from patients on how they feel or function, without requiring interpretation from others, using standardised symptom and/or QoL questionnaires, 11 and are often in electronic format (ePROs). However, while patient-reported experience measures (PREMs), which allow patients to self-report their experience of receiving healthcare, have been collected since 2017, 12 PROs are still not routinely and systematically collected to manage individual patient care in the UK: meaning that many patients and some members of the multidisciplinary team caring for them are inexperienced in PROs and related concepts.
Yet the international body of evidence exploring the use of PROs in nephrology settings is growing, [13][14][15][16][17][18][19][20][21][22] demonstrating acceptability and feasibility of ePRO capture [23][24][25] and how ePROs can support the delivery of patient-centred care. 26 27 However, the overall impact and benefit of PRO use in dialysis care is yet to be established. 28 In comparison, PRO research in oncology has shown defined benefits ranging from improved QoL and reduction in hospitalisations to overall survival 29 and even cost-effectiveness. 30 In November 2020, an online UK Summit led by the UK Renal Association, entitled 'ePROs for the Kidney Patient Community', was held to create a comprehensive, UK-wide roadmap to facilitate and optimise the collection and use of ePROs for the benefit of people with chronic kidney disease (CKD). This summit highlighted the importance of key stakeholder engagement, including patients and front-line clinicians, early and at all stages of design and implementation. 31 To inform and direct future research plans, this study aimed to investigate the methodological basis for routine PRO assessment through exploration of the experiences, views and perceptions of patients and healthcare professionals (HCPs) on implementation and use of PROs, particularly ePROs, in HD settings.

METHODS Design
The qualitative research question: 'What are the experiences, views and perceptions of patients undergoing HD on the implementation and use of ePROs in routine care and research settings?' Epistemologically, pragmatism, which is set within a paradigm of enquiry processes and research practicality, 32 provides the philosophical framework to answer this question. A core assumption of pragmatism is that research should proceed from a wish to produce actionable knowledge 33 ; allowing the researcher to select the research design and the methodology deemed most appropriate. 34 These foundations led to the decision to use the Consolidated Framework for Implementation Research 35 to offer a theoretical perspective and a qualitative descriptive (QD) methodology. [36][37][38] This is particularly useful for healthcare studies focused on discovering the who, what and where of events or experiences and gaining understanding of inadequately understood phenomenon. Kim et al 38 describe QD as the 'label of choice' when an unambiguous description of a phenomenon is desired or information is sought to develop and refine questionnaires or interventions. 39 This choice of methodology led to the utilisation of the following methods.

Participant selection
Participants included adults (≥18 years), receiving HD (in centre or at home), able to provide valid informed consent and converse in everyday English. Patients were excluded if they were not deemed established on HD or had been undergoing HD <3 months, or if they had an active intercurrent medical problem requiring enhanced routine clinical care. 40 Participants were identified and recruited between July 2018 and November 2019 by the lead author. Eligible patients were primarily approached face to face in the dialysis unit; patients dialysing in centre were approached before dialysis session and patients who dialysed at home (home haemodialysis (HHD)) were approached when they attended for clinic. Purposive sampling was undertaken to achieve maximum variation across age, gender, ethnicity, time on dialysis and comorbidities. 41 HCPs were recruited from the broader renal team, and initially contacted by email by the lead author; they included healthcare and administrative assistants. 40 Setting Data were collected from 22 patients undergoing HD and 17 HCPs in the UK (see tables 1 and 2). All participants were being treated via, or working at, a large regional hospital. To accurately reflect the diversity within the dialysis population, patients being treated in centre (n=15) were recruited from two satellite units as well as seven patients choosing to dialyse at home. Non-medical members of the multidisciplinary team were targeted from these two units, one in a city and one serving mainly rural communities. All HCPs currently working in the home setting (n=5) had extensive previous experience of in-centre dialysis delivery.

Data collection
All consenting participants took part in an audio-recorded semistructured interview with the lead author, either face to face or by telephone. Ethical approval was gained for follow-up interviews, but none were required. Patient interviews were conducted at the dialysis unit for those dialysing in centre (n=15) and at home for the HHD group (n=7). Since these interviews were conducted in patient homes, family members were sometimes present at the request of the patient, but did not take an active role in the interview. HCPs were interviewed in a private room at their workplace. Topic guides were used to steer Open access and support the interview process (see online supplemental files 1 and 2). These guides were piloted with one participant from each group and then refined iteratively during the collection phase in response to initial findings. Field notes and in-depth memos were created after each interaction. Since PROs are not routinely collected in the UK, including the hospital trust where this research was undertaken, it was recognised preinterview information was required to aid the quality of discussion around PROs and future implementation. Therefore, participants were provided with a diagram of a core outcome set selected specifically for use in HD trials, to illustrate the position of PROs in outcome measurement 42 and example PROs from a recent systematic review and supported by our local renal public and patient involvement group: Kidney Disease Quality of Life Short Form, 43 Kidney Disease Quality of Life 36 44 and Integrated Patient Outcome Scale-Renal. 45 Patients in all UK renal units are invited to complete the annual renal PREM to report their experience of kidney care. This report demonstrates variation in experience across centres and can be used to drive organisational change and improvement 12 ; some patient  Open access participants indicated they had completed the annual PREM.

Analysis
Using codebook thematic analysis, 46 a coding framework, drawing on the Consolidated Framework for Implementation Research (CFIR), 35 was used to deductively analyse transcripts, with further new subthemes developed inductively through data engagement and the analytical process. The CFIR is a widely used conceptual framework developed to guide systematic assessment of factors that might influence implementation and effectiveness, including assessing potential barriers and facilitators in preparation for implementing an innovation (see figure 1). 35 47 Primary data analysis was conducted by the lead author, with two investigators (CMcM, DK) reviewing coding for consistency and appropriateness. As the lead author was a renal research nurse conducting this research as part of a Clinical Doctoral Research Fellowship, she was known to some HCP participants. This information was declared and discussed during the valid informed consent process. Additionally, a reflective research diary, memo writing and discussion with the study management team were used to try to minimise the influence of prior relationships on analysis. Data analysis was supported by qualitative data analysis software-QSR NVivo V.12. Participant verification, 48 to check that the transcript correctly documented the discussion, was undertaken on one transcript from each group-no discrepant comments were reported. Data collection and analysis continued until saturation was achieved, that is, no new information pertinent to the research question was being generated by further interviews (see online supplemental tables 1 and 2). 49 Patient and public involvement Research on the use and implementation of PROs in nephrology settings was prioritised by the local kidney patients charity. An existing patient and public involvement (PPI) group was used and a study-specific PPI group was convened to help develop the research question, design this study and the associated fellowship application. Patients were consulted on the study documentation, including topic guides and example materials (see online supplemental files 1 and 2). A summary of study findings will be made available for study participants.

Participant characteristics
Participant characteristics are summarised in tables 1 and 2.
The patient sample was broadly representative of prevalent HD population in the UK. 50 Data saturation was deemed achieved after interviewing 16 HCPs and 15 patients (see online supplemental tables 1 and 2 for further detail).

Open access
Key findings Analysis identified the following themes, which are presented in line with the CFIR key domains. Although presented in a linear fashion, the five domains and their respective constructs cannot be considered in isolation, all interact to effect implementation. Figure 1 shows the conceptual framework and associated findings. Illustrative quotations are provided in table 3.
Intervention characteristics: factors associated with design and quality of the intervention, including how intervention is perceived The importance of demonstrating PRO efficacy and impact Both patients and HCP participants felt that PROs could support the delivery of person-centred care through shared decision-making and management in dialysis settings. However, HCP interviewees highlighted the key challenge was not the physical collection of PROs, but how the data were then used to improve outcomes. For patients, it was key that any time spent completing questionnaires should be rewarded with review and appropriate action, that is, not a 'tick-box' exercise.
HCPs, particularly nephrologists, extolled the importance of PROs in research settings.

Intervention flexibility
The topic guide initiated discussions with participants on key practical considerations, including frequency (of PRO completion), optimal timing (around dialysis), preferred setting (home or in centre), favoured mode of administration (electronic or paper versions) and interpretation and feedback of the responses.
It was clear from the patients that a fixed means of implementing PROs would not meet the requirements of this heterogeneous group. Any system would need to be flexible while maintaining maximum simplicity. Most patients felt they could complete electronic measures if required, but some strongly favoured paper options. Most interviewees stated that self-completion was possible but felt some would need physical or emotional support from carers. A few patients indicated a desire for assistance with information technology (IT) aspects until they became familiar. Several patients alluded to the need to 'compartmentalise' their dialysis by conducting all dialysis-related activity in centre or by having discrete facilities and times for dialysis if being treated at home; suggesting that PRO completion would need to be undertaken at defined times/settings within their schedule. Others were less concerned about daily reminders of their disease and management, so were open to completion timings/ settings that were more variable.
HCPs discussed the promise of electronic capture to support enhanced management of chronic symptoms, but some expressed concerns about potentially missing acute signs and effectiveness of associated safety reporting and actions. Two HHD patients foresaw the potential benefits of automated safety alerts associated with electronic capture. However, one patient noted that it was important that any automated information or self-help advice should not conflict with information given face to face by the doctor.
Participants were asked for their perspectives on computer adaptive technology, a type of assessment in which questions are generated specifically for each individual, using item response theory. This was a new concept to nearly all participants, but most quickly grasped the underlying theory after a short explanation and were supportive of the idea, recognising the potential to stop redundant questions and save time. (See table 4 for overview of practical considerations.) Outer setting: the wider societal, economic and organisational contexts in which the stakeholders and organisation implementing the intervention reside Identifying outcomes that matter There was a general agreement among all participants that it was important to ensure measurement of 'what outcomes matter most' to patients. 51 There was a broad agreement from patients that the example PROs they had been provided with were comprehensive in covering the key symptoms facing patients undertaking HD. Furthermore, they agreed with findings from the Standardised Outcomes in Nephrology (Haemodialysis) initiative (SONG-HD) 42 that fluctuations in HRQoL mattered more, to them, than biomedical outcomes. The importance of these outcomes was acknowledged by the HCPs, but it was felt that deep exploration of some PRO data fell outside the remit of the nephrologist or dialysis nurse and there was anxiety about acting outside their competency and the associated risks of litigation.

The 'Bigger Picture'
Several patients highlighted problems with continuity of care and lack of cohesion between primary care and their dialysis provision. One HHD patient felt the use of PROs could assist uptake of home therapies by demonstrating better overall outcomes/HRQoL for patients managing their own dialysis. Participants in both groups reflected that PROs could help support shared decision-making by targeting and prioritising discussions according to the patient's agenda.
Inner setting: the structural and cultural contexts around where the implementation will take place Compatibility of PRO use and approaches to care in HD settings Discussing potential implementation and how participants perceive the current situation as needing change, patients and staff alike discussed the approaches to care within dialysis settings. Patients clearly described a 'task orientated' style of care in centre, with a focus on practically administering HD, versus a more patient-centred model discussed by those dialysing at home. HHD patients dialysing themselves felt they had developed a level of expertise and the increased 'control' had improved their HRQoL. They indicated current communication pathways were effective and that the HHD team was responsive   Consensus that electronic feedback is ideal. Responses outlined in letter to patient or face to face in clinic to allow 'probing'-but this requires resource. Agreement that longitudinal data would be advantageous to see trendspreference for graphical rather than tabular form-but scales need to be well thought through, 0-3 not considered 'sensitive' enough to be able to show changes-preference for EQ-5D thermometer scale… 'but a 'Blunt tool'good clinician should pick up sensitive changes before PROs would.' HCP11 No time to read lots of free text.
Setting of feedback Currently most consultations take place while the patient is dialysing. Patients gave mixed responses to the wish to be seen in private, most did not want additional or extended visits at the dialysis unit and seemed resigned to being seen in open bays. If medical staff were providing feedback in person, pragmatically best to do this in clinic, it was acknowledged this feedback can take place at the bedside during dialysis but participants noted this may affect the quality and content of the discussion.
Who provides feedback No overall preference, but one patient felt more comfortable talking to nursing staff. Variation on responses-some thought medical staff (but concerns raised around time and workload), others thought nurses (some anxiety regarding time constraints and knowledge/experience of junior nursing staff to know how to manage symptoms or issues raised by PROs). 'Need clear process for review and feedback-'can't have 6 nurses going back to patient to discuss responses'.' HCP16 EQ-5D, EuroQol-5 Dimension; HCP, healthcare professional; IT, information technology; PRO, patient-related outcome.

Table 4 Continued
Open access and holistic in their approach to care. Analysis of patient and HCP data suggested that time constraints were the major reason for a task-based approach in centre with both patients and staff exhibiting a desire to complete dialysis sessions with as little impediment as possible. Correspondingly, most in-centre patients did not feel staff had time to have long discussions and some suggested PROs might help rectify this. There was no discernible variation in the views of the HHD cohort on the practicalities of PRO collection.
Part of a wider framework: the 'information loop', the role of PROs in addressing training needs and health literacy HCP data analysis highlighted the importance of education, training and support for successful implementation. It was indicated that while medical staff needed training in PRO interpretation, such as rating scales, nurses might need a broader programme on use of PROs as well as associated chronic disease management. There was disparity indicated in the health literacy of the patient group; some HHD patients appeared expert in their illness and treatment, while some in-centre patients appeared less confident in their knowledge.

Characteristics of individuals: factors associated with individuals involved in implementation Previous experience of using PROs
Patients expressed an overall lack of awareness and experience of PROs. Many had completed annual PREMs but highlighted a lack of feedback or action. Some patients expressed general anxiety about questionnaire completion, linked to their experience of externally administered questionnaires for other agencies: for example, Personal Independence Payment surveys assessing entitlement to extra costs associated with long-term ill health or disability. When reviewing the example PROs, it was noted that some patients, particularly those from minority ethnic backgrounds, flagged the potential difficulty around asking about sensitive issues such as sexual function. While the participants themselves were happy to discuss such issues, they recognised that not all patients might be. All nephrologists interviewed had experience of using PROs in research settings, but none had regularly and systematically collected PROs in routine care. PRO use in any setting was largely a new concept for nursing staff.
There was a confusion around the concepts of PROs versus PREMs, expressed by both patients and HCPs. Participants found it hard to distinguish experience of care from outcomes and used terms interchangeably.

Multidimensional aspects of ESKD and consequent challenges
Many of the patients in the study had multiple comorbidities and associated symptoms, reflective of the wider HD population. Patients indicated that it was often hard to know which symptoms related to their ESKD and/or treatment, and which were associated with other diseases or advancing age; leading to anxiety about what to raise during a consultation. It was suggested that PRO data review and feedback gave a chance to discuss symptoms and potential causes, thereby potentially providing reassurance. However, some clinicians thought it was outside their role to manage non-nephrology-related outcomes presented by PROs and that it would be difficult to disentangle several, possibly unrelated, symptoms. They feared focusing on symptoms that were not currently being experienced or intractable could cause frustration or anxiety for themselves and the patients. Some patients gave a contrasting opinion, revealing the chance to be heard, even without a solution, was often sufficient to maintain the patient-clinician relationship. There was also concern that an over-reliance on PROs could result in a distraction from other important clinical issues.
The experience of life on dialysis was highly varied, with some participants exhibiting signs of depression, anger or acceptance, as well as reporting multiple symptoms.

The process of implementation
Supporting the process of implementation The analysis identified leadership, the identification of champions and a 'bottom up' approach to communication and shared solutions among both patients and clinicians as key factors supporting implementation. All participants emphasised the importance of support during completion; however, patients highlighted this need not always be delivered by healthcare staff. Peer-topeer support and non-clinical champions, that is, administrative staff, might assist. HCPs felt a comprehensive launch was important and that individual roles should be clear. They reflected that senior members of the clinical team would be opinion leaders, and any change agents would need to understand the dialysis setting. Evaluation and reflection were important process components to recognise and deal with any unintended consequences.
Overarching themes: barriers and facilitators to effective implementation Across all CFIR constructs, analysis identified potential barriers and facilitators to the introduction of PROs.

Potential barriers
Nephrologists cited a lack of evidence base supporting the use of PROs in routine kidney care and were concerned regarding the risk of overmedicalising the patient experience. There were perceived time barriers for staff, that is, workflow interruptions, additional obligations caused by PROs; with nurses perceiving quality time with patients in centre as limited. HCP participants argued that nursing documentation had lessened available time, as it often required recording on digital devices away from the bedside. They feared patients were being overburdened by questionnaires, particularly the less health literate.
In contrast, patients were often already aware of the complications associated with ESKD and HD. Many had achieved a degree of acceptance and some were reassured that the symptoms were expected and not something new Open access to deal with. Frustration would only arise if, having taken time to complete the questionnaires, no action was taken. Both groups agreed that IT issues, that is, inability to log in, no Wi-Fi, could be a barrier.

Potential facilitators
Several HCPs considered how PROs might work to deliver a relative advantage over current systems to support more patient-centred care. Participants felt PROs could be a communication tool-acting like a 'tin opener'; but requiring that responses be carefully probed, highlighting that this required appropriate skills and training. Others saw the measures as an aide-mémoire which could help target the consultation and even save time; as could the possibility of remote management of care using ePROs. Perhaps, most importantly, PROs were seen by both patients and HCPs as a way to get to know the patients and hence deliver more meaningful care.

DISCUSSION
There is a growing body of published, peer-reviewed literature exploring the experiences of both kidney patients and multidisciplinary kidney HCPs with ePROs. 13 17 23 26 27 52 Previous studies have included non-dialysis-dependent CKD and peritoneal dialysis populations, 17 23 27 evaluating existing ePROs and associated delivery systems. This paper adds to the corpus by using semistructured interviews to gain rich data to inform and optimise future ePRO implementation in an HD population naïve to ePRO collection and clinicians unused to routine and systematic ePRO use.
The key findings of this study are that while patients and HCPs support the concept of PROs, further evidence of their potential benefit is required for effective implementation. It emphasises that any system should be flexible and measure what matters most to patients. Most importantly, the data collected should be acted on. There was a general lack of awareness and experience of PROs particularly among patients and nurses, with concern among the HCPs that PRO capture may highlight issues they might have neither the experience nor resources to manage. Therefore, a comprehensive implementation strategy is required to support any delivery, which involves strong leadership, patient and clinician involvement and ongoing training.
This study highlighted the importance of getting 'buy in', that is, gaining acceptability, from these stakeholders. This could be achieved by demonstrating evidence on their potential benefits thereby increasing trust to warrant practice change. Clinicians particularly questioned whether positive effects on survival, reported QoL, patient-clinician communications and cost efficiencies demonstrated in oncology 29 53-55 could be replicated in HD settings.
The body of evidence around ePROs in nephrology is emerging. Studies from North America demonstrate the feasibility of electronic capture of PROs in HD 19 24 and an Australian pilot study is currently exploring the feasibility and acceptability of ePRO capture and feedback among patients receiving HD in the Symptom Monitoring With Feedback Trial. 20 In advanced CKD populations, the Renal Electronic Patient Reported Outcome Measures (RePROM) study is piloting the use of an ePRO for remote symptom monitoring in the UK, 56 while the Ambu-Flex telePRO system is used to manage renal follow-up in Denmark. 25 Aiyegbusi et al 17 explored key stakeholder perspectives on the use of PROs in these predialysis patients and their findings are consistent with this study, particularly regarding potential benefits and administrative aspects; suggesting PRO data collection early in the patient pathway can be instituted and continue as illness advances through to renal replacement therapy or even conservative care.
A review and synthesis of evidence is currently being undertaken to investigate how PROs might work to enhance patient-centred care in renal settings, to offer strategy and guidance at individual and aggregate levels of decision-making. 57 For effective multiple uses of data, implementation needs to be viewed within the context of complex data linkage and accessibility issues. Studies in the UK and Australia are currently exploring and testing such linkage of symptoms and QoL data to the Australia and New Zealand Dialysis and Transplant Registry and UK Renal Registry. 20 22 58 However, the purpose of data collection must be clear. Participants in this study confused the concepts of PROs versus PREMs, understandable given that experience of undertaking HD is intricately linked to both HRQoL and symptoms. The integrated use of both measures, side by side, warrants further investigation. Anxieties about purpose and data sharing could affect patient engagement; clear communication of roles and expectations should be undertaken.
While guidance exists on what outcomes to measure in research 5 6 and routine practice 9 this has not necessarily been centred on routine capture and feedback to guide individual care. Consequently, it is not clear which measure(s) should be used to capture data in a nonburdensome way, while providing sufficient measurement properties to support both single patient monitoring and aggregation of data where required, meaning further enquiry is needed.
The general lack of awareness and experience of PROs and concern that PRO capture may highlight issues that HCPs should not or cannot deal with, leads to a significant finding that PRO implementation must sit within a broader educational framework. PROs could be used to support wider initiatives and training, especially in the nursing group, who can then cascade information and self-management skills to patients, thereby increasing overall patient health literacy. This could be considered as closing an 'information loop'. There is already evidence that patient education is associated with better patient outcomes 59 and new strategies and quality improvement programmes exist such as Shared HD, a UK programme Open access aiming to support patients receiving in-centre HD to be more independent and confident in participating in aspects of their own care. 60 Potential barriers are cost and resources, but increasingly, accredited online learning facilities are available. However, it is acknowledged, staff in this study indicated a preference for face-to-face training. Education and training on PROs would be needed for all stakeholders.
This study identified time and workflow interruptions as key barriers to implementation. Rotenstein et al 61 found that following initiation of routine PRO collection in surgical settings, such concerns shifted as clinicians became comfortable with new processes. There was even a suggestion that PROs could enhance physician satisfaction and prevent 'burnout'. 61 Tong et al 52 interviewed the nephrologists, who also identified resource constraints and uncertainties in how to prioritise, measure and manage a range of competing comorbidities and broader QoL outcomes in a clinical setting that is technically demanding and traditionally focused on biochemical factors; findings mirrored by this study. Such anxieties will need addressing.
During the SARS-CoV-2 pandemic, data from the UK Renal Registry showed that patients undergoing HD experience a relative risk of mortality of 45.5% compared with the general population. 62 This vulnerable population has been unable to effectively shield, requiring regular dialysis treatment with associated risks around shared transport and waiting areas. Various strategies have been employed to reduce risks 63 but new ways of care delivery were required. The pandemic has irrevocably changed healthcare, with increased use of virtual services 64 and remote clinic visits. The addition of ePROs to readily available biomedical data means that clinicians could more effectively deliver patient-centred care without the necessity of the patient being physically present. This study also suggests that remote symptom monitoring could offer patients the safety and confidence to dialyse at home and arguably ePROs could assist the HHD service in maintaining its patient-centred approach while serving ever increasing numbers.
There are limitations to this study. Participants needed to be English speakers; this could affect transferability of findings. Views of carers were not specifically sought but their influence and importance were clearly identified by patients, suggesting further research targeting this group is warranted. Critically, data collection took place before SARS-COV-2 pandemic and experiences and perceptions around digital data capture and new approaches to healthcare delivery may well have shifted.
To conclude, the SARs-COV-19 pandemic has caused an irreversible shift in healthcare delivery, with increased use of digital communication and assessment. While the nephrology community, both patients and HCPs, are largely supportive of the concept of ePROs, there remain caveats to their routine and systematic use. Stakeholders need to be convinced by empirical evidence, considering the best available measures and methodological considerations. By exploring the experiences, views and perceptions of major stakeholders, this study identified key factors at organisational and individual levels which would assist effective implementation of ePROs. Further research will then be required to evaluate any subsequent ePRO interventions to empirically demonstrate the impact and benefit of their use to the dialysis community.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.
Open access This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https:// creativecommons. org/ licenses/ by/ 4. 0/.